State updates: California, Massachusetts, Texas

California: Major new reporting reg

All pharmacies licensed to dispense medications to California patients — including resident and non-resident pharmacies — will need to report all medication errors to the Institute for Safe Medication Practices (ISMP) within 14 days of discovery starting in early June, and must register with this new reporting system by May 24, 2025. (You may already have received instructions from ISMP.) 

There is a lot more you need to know, especially depending on whether you’re part of a Patient Safety Organization (PSO) such as APMS, which is a free service APC provides its PFM members. APC’s Tenille Davis explains those details — including what’s required, what to do if you’re part of (or not part of) a PSO, the implementation timeline, and documentation requirements; read what she wrote here.

APC is actively monitoring the implementation of this new mandate, and we’re working to clarify how it affects PSO members. We’ll have more information to share at our May 7 PFM Public Policy Briefing.

Massachusetts: Misguided bill, confusing memo

APC has sent two comments off to Massachusetts — one to its legislature’s Joint Committee on Public Health and one to its Board of Registration in Pharmacy (BRP).

To the public health committee: We submitted comments concerning S.1497, a bill that would restrict — and in some cases eliminate — the ability of 503A pharmacies to source compounded medications for patient-specific dispensing from 503B outsourcing facilities. Such restrictions, we wrote, “[W]ould effectively prohibit 503B sourcing, even when used for lawful, prescription-based dispensing. This would place Massachusetts outside the regulatory norm.”

To the pharmacy board: In a similar vein, we asked the BRP to reconsider its April 3 memo that seemed to restrict the ability of 503A pharmacies from sourcing compounded drugs from 503B facilities — something that is clearly defined and supported by FDA guidance. “Some Massachusetts pharmacies now report hesitancy from state inspectors or licensing staff to permit 503B-sourced medications to be used — even when clearly intended for patient-specific dispensing.”

And we got good news yesterday: the board rescinded the order.

Texas: Bad bill fails in committee

Last week we told you about a bill in the Texas legislature that would have added labeling requirements to compounded medications that would violate federal law — “A Texas proposal you couldn’t comply with if you wanted to,” we called it.

Good news: That bill went down in committee and won’t be an issue this year. (The less-good news: It failed by the smallest possible margin, so it could pop up again.)